1. Field of the Invention
This invention relates generally to pharmaceutical compositions having utility as diuretics and aldosterone antagonists, and specifically relates to spironolactone compositions of such type which are aqueously homogenizable in character.
2. Description of the Art
Spironolactone is a steroidal lactone compound having a significant aldosterone antagonistic character, which has been widely employed as a diuretic.
The structure and preparation of this compound are disclosed in U.S. Pat. No. 3,257,390 to A. A. Patchett.
Although spironolactone is a highly effective aldosterone antagonist, it has the instrinsic disadvantage that it is practically insoluble in water.
In instances where spironolactone has been employed in solid formulations for oral administration, it has been typical practice to utilize this compound in finely divided form, e.g., as a micronized powder, in tablets or capsules, which subsequent to ingestion are dispersed from the solid dosage form into the gastro-intestinal medium. Specifically, the micronized spironolactone powder has been utilized in such solid dosage forms as either compressed tablets or loose powders in capsules, to facilitate the bio-availability of this practically insoluble substance.
In the control of hyperaldosteronism, in infant or elderly individuals, such solid spironolactone dosage forms are highly disadvantageous. It would be a significant advance in the art to provide a liquid dosage form which is adaptable for oral administration to such infant or elderly individuals, susceptible to or suffering from hyperaldosteronism.
Accordingly, it is an object of the present invention to provide improved spironolactone dosage forms, either in the form of a solid powder composition which may be readily aqueously homogenized prior to ingestion, or else in the form of an aqueous spironolactone suspension.
It is another object of the invention to provide spironolactone formulations of such type which are readily formulated and easily administered by oral administration.
Other objects and advantages of the invention will be more fully apparent from the ensuing disclosure and appended claims.